SFDA Drugs Dataset Analysis

SFDA Drugs

Summary

This documents provide general description SFDA drugs with comparing between Saudi drugs manufactured and non-Saudi manufactured drugs such as comparing prices, drug type, route of administration. shiny app is also available which provide interactive searchable table, interactive map, plot for SFDA drugs and paracetamol calculator go to SFDA shiny app.

Introduction

The Saudi Food and Drug Authority (SFDA) was established under the Council of Ministers resolution as an independent body corporate that directly reports to The President of Council of Ministers. The Authority objective is to ensure safety of food and drug for human and animal, and safety of biological and chemical substance as well as electronic products.

The main purpose of the SFDA establishment is to regulate, oversee, and control food, drug, medical devices, as well as to set mandatory standard specifications thereof, whether they are imported or locally manufactured. The control and/or testing activities can be conducted in the SFDA or other agency’s laboratories.

Moreover, the SFDA is in charge of consumers awareness on all matters related to food, drug and medical devices and all other products and supplies. it is consumer responsibility to ensure unregistered drugs/products is tested against safety and efficacy

Data description

human drug dataset will be used and analyzed, it is available in SFDA website.

Summary of variables in the dataset:

Variable Description
Register Number Every drug has unique registered number
Register Year Year of drug registration
Product type All drugs for human use
Drug Type Generic, biological, NCE (new chemical entity), Radio pharmaceutical or Health products
Sub-Type Allergen product, biological bio, biosimilar, Biotechnology product ..etc
Scientific Name Generic Name
Scientific Name Arabic Generic name in Arabic
Trade Name Commercial name
Trade Name Arabic Commercial name in Arabic
Strength Strength of active ingredients in the drug
Strength Unit Strength Unit such as mg, g , ml …etc
Pharmaceutical Form solution, powder for inj..etc
Administration Route Route of Administration
AtcCode1 Anatomical Therapeutic Chemical (ATC) Classification, main pharmacological group
AtcCode2 Pharmacological or Therapeutic subgroup
Size drug size
Size Unit unit size such as ml
Package Types Blister, Bottle, Vial, Ampule ..etc
Package Size size of the package
Legal Status prescription or Over counter drug
Product Control controlled/uncontrolled
Distribute area hospital or pharmacy
Public price public price for the drug in SR
shelf Life length of time that a drug can be stored in months
Storage conditions specific requirements for registered drugs
Marketing Company a company that provides marketing services for drugs
Marketing Country a country that provides marketing services for drugs
Manufacture Name Manufacture Name of drugs
Manufacture Country Manufacture Country of the drugs
2Manufacture Name second Manufacture Name of drugs
Manufacture Country Country of the drug manufacturer
Secondary package manufacture
Main Agent company that provides organizing transactions between two other parties.
Second Agent there could be more than 1 agent for the same drug
Third agent there could be more than 2 agents for the same drug
Marketing Status all drugs are marketed
Authorization Status valid or suspended
Drug Satatus Saudi / non-Saudi manufactured drugs

Data Comparison

Drug_Status percent
Non Manufactured Saudi Drugs 69.67911
Saudi Manufactured Drugs 30.32089

overall, Saudi drugs contributes to only 30% of registered drugs.

#### Exclusive Drugs:

222 drugs are synthesized exclusively. 1252 drugs synthesized only outside SA, as we have 1782 different drugs, It is 70% of total distinct drugs. However looking to Saudi drug list, there are so different combinations of electrolytes, there also might be some spelling issues which may slightly affect the result for both arms

RegisterYear

Year of drug registration

Starting of Saudi company was almost after 90s, before that, it was markted by other countries. The peak in recent years, the presences of covid-19 might affect increasing drug registration especially for non-Saudi drugs.

Public Price

##   Public price      
##  Min.   :      0.0  
##  1st Qu.:     17.2  
##  Median :     45.0  
##  Mean   :   1331.9  
##  3rd Qu.:    151.5  
##  Max.   :1759274.3  
##  NA's   :3

the data for price has extreme values could starts from 0 price (influenza vaccine) to a very high price 1759274.3 which make it impossible to draw in meaningful graph, that is issue solved by Shiny app which you can navigate the prices for each country in one plot without too much overlapping!

in general, higher prices in recent years for hospital distribution,

pleas note that I determined the price based on mean, however the mean is affected by extreme values, although the 3rd Qu 151.5. There are 212 missing values in the plot which cover less than 3% of the data.

Histogram for price!

## Warning: Removed 1234 rows containing non-finite values (stat_bin).
## Warning: Removed 4 rows containing missing values (geom_bar).

more cheaper medications is synthesized

DrugType

almost 2/3 of drugs are generic followed by A New Chemical Entity drugs.

DrugType n
Generic 4735
NCE 2263
Biological 620
Radiopharmaceutical 6
Health 4

most common drugs are Generic or NCE, It makes a sense because biological and radiophamaceticals are since these drugs used in serious diseases such as cancer! description of each type

1- A generic drug is a medication that has exactly the same active ingredient as the brand name drug and yields the same therapeutic effect.(the link)

2- A New Chemical Entity (NCE) is a drug that does not contain any active moiety that has been approved by FDA with any other application. The manufacturers of an innovator drug generally develop a NCE during the early development stage of the product cycle. The NCE, then, undergoes various clinical trials in order to transform into a drug product(the link).

3- Biological drugs (commonly referred to as ‘biologics’ or ‘biopharmaceuticals’) are drugs produced through biological processes. They currently target diseases which, hitherto, had very limited or no available treatment options – including several types of cancers, autoim- mune diseases and other non-communicable diseases(the link).

4- Radiopharmaceuticals are radioactive chemicals or pharmaceutic preparations, labeled with a radionuclide in tracer or therapeutic concentration (the link).

Comparing Drug type against price

biological drugs have higher prices. typically They mimic proteins and other molecules found in living organisms and can target harmful entities, such as some cancer cells, with great accuracy; many of the most promising new drugs for cancer and other diseases fall into this class. Biological drugs tend to be larger, more complex molecules than drugs synthesized through chemical reactions, which adds to production challenges and makes them costly.

ADMINSTRATION ROUTE

finding our focus

Saudi manufacturer focus more on oral drugs followed by Iv drugs but then what kind of iv drug provided?

Scientific Name Trade Name
dextrose, sodium chloride 63
dextrose 58
sodium chloride 21
water 18
sodium bicarbonate 12
magnesium chloride6h2o, potassium chloride , acetic acid , calcium chloride 2h2o , dextrose , sodium chloride 9
balanced electrolytes 8
magnesium chloride6h2o , potassium chloride , acetic acid , calcium chloride 2h2o , dextrose , sodium chloride 8
potassium chloride, sodium chloride 8
potassium chloride 7

ok, that’s what I expect, manufacturers focus really on basic treatment which is not not be specific to any disease. we have also import electrolytes &Normal saline from other countries.
let us try on oral medications

Top 10 oral manufactured drugs

Scientific Name Trade Name
pregabalin 41
tadalafil 29
levetiracetam 27
montelukast sodium 26
etoricoxib 22
olanzapine 21
quetiapine fumarate 21
azithromycin 20
sildenafil citrate 20
glimepiride 18

This is gives us better idea than IV drugs pregabalin in the top,anticonvulsant and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, and generalized anxiety disorder. Also, it used for diabetic neuropathy. pregabalin in last 5 years this drug has been added to controlled drugs because they found that it cause addiction. Many patients still addict to this medication. so it is consumer need! 24 drug registration of pregabalin after become controlled

  • Montelukast used as prophylaxis and chronic treatment of asthma and Allergic or Perennial Rhinitis which is expected because of our dusty weather
  • Tadalfil & Sildenafil used in pulmonary hypertension and impotence
  • Levetiracetam is anti-epliptic
  • Olanzapine $ Quetiapine is anti-psychiatric medications. they can be overuse but it is indicator of mental health issues
  • Glimepiride, finally we got is an anti-diabetic medication!
    Honestly, I was expected antidiapetic & antihypertensive medication to be in the top, our hospitals are full of diabetic & hypertensive patients

Top 10 oral imported drugs

Scientific Name Trade Name
quetiapine fumarate 40
amoxicillin, clavulanic acid 34
ciprofloxacin 32
montelukast sodium 28
etoricoxib 27
tadalafil 25
glimepiride 24
clarithromycin 23
ibuprofen 22
paracetamol 22

there are some common drugs betwen top saudi manufacucred and starting by Anti-psycatric indicate increase psychiatric diseases in Saudi Arabia let see when quetiapine was registered, 6 times all of them in Saudi Arabia in last 3 years.

Comment on mental health on Saudi Arabia

the first national study of COVID-19 impact on mental health from Saudi Arabia, the risk of depression in Saudi Arabia increased by 71.2% between May and August 2020 compared to 2018. Other studies demonstrated that The risks of major depressive disorder and generalized anxiety disorder are relatively high. studies within the Reference

Top 10 Intramuscular Saudi Manufacuerd drugs

Scientific Name Trade Name
ceftriaxone 4
cefazolin 2
cefepime 1
cefotaxime 1
chorionic gonadotrophin (hcg) 1
diphtheria, hemophilus influenzae b, pertussis, tetanus, hepatitis b 1
ketoprofen 1
piroxicam 1
vitamin b6 (pyridoxine ) , vitamin b1 (thiamine hydrochloride) , vitamin b12 (cyanocobalamin) 1

top 4 drugs are antibiotic

Manufacturer Countries

top 10 Manufacturer Countries

Manufacture Country n
Saudi Arabia 2315
Jordan 629
Germany 562
United States 452
United Arab Emirates 319
United Kingdom 317
France 290
Italy 287
India 268
Switzerland 238

drugs imported mainly from Jordon followed by Germany

Shelf life

length of time that a drug can be stored in months. It differ than expiration date. From medical perspective: The shelf life generally relates to a drug’s quality over a specified period of time, whereas the expiration date relates to both quality and safety of a medication at a specific point in time(the link).

as it shown, most of medications shelf life between 20 to 40 months which is almost equal to 2-3 years price vs shelf life

General Information

Top 10 Highly consumed Drugs

many trade drugs for same generic drugs means that is highly consumed

Scientific Name Trade Name
sodium chloride 111
dextrose, sodium chloride 82
dextrose 78
diclofenac sodium 63
amoxicillin, clavulanic acid 62
paracetamol 62
quetiapine fumarate 61
ciprofloxacin 55
montelukast sodium 54
tadalafil 54

Sodium Chloride Normal saline, it is widely used in the hospitals which make a sense that is the most common one

DExtrose Also widely used, it is simple sugar, so mainly used for Hypoglycemia, it is used along with Sodium cloride

Paracetamol & diclofinac both are pain killers, both are widely used inside and outside hospitals, both have oral form, In general, Diclofinac is available also as intermuscular which make it prefered mild to moderate pain killer in the ER rather than parecetamol (IV) which may take longer time.

amoxicillins&clavunic acid β-lactam antibiotics (beta-lactam antibiotics), it has wide antibactrial spectrum covering & it taken orally, generally it can treat: : Ear, Nose, & Throat Infections,Genitourinary Tract Infections,Skin & Skin Structure Infections,Lower Respiratory Tract Infections

quetiapine it is used for psychiatric disorders such as: Major Depressive Disorder, Schizophrenia,Bipolar I Disorder & insomnia

ciprofloxacin Fluoroquinolones antibiotics, unlike amoxicillin which is available only in oral dose, cipro also has IV form which make it suitable for inpatients hospitals, it covers lower respiratory tract infections such as Pneumonia, urinary tract infections (UTI), bone & skin infection.

montelukast it is used as prophylaxis and chronic treatment of asthma and Allergic or Perennial Rhinitis

What are the top 10 registered priced drugs?

Public price Scientific Name DrugType RegisterYear Manufacture Country AdministrationRoute
1759274.32 voretigene neparvovec Biological 2020 United Kingdom NA
1633500.00 tisagenlecleucel Biological 2020 United States Intravenous
394762.50 nusinersen NCE 2019 Italy INTRATHECAL
95189.65 eliglustat NCE 2018 Ireland Oral
83063.45 catridecacog NCE 2015 Denmark Intravenous
77094.89 larotrectinib NCE 2020 United Kingdom Oral
72568.25 grazoprevir, elbasvir NCE 2016 Ireland Oral
65083.35 ipilimumab Biological 2015 United States Intravenous
56854.95 erdafitinib NCE 2021 Italy Oral
52774.45 lanadelumab Biological 2020 United States Subcutaneous

Voretigene Neparvovec is an adeno-associated viral gene therapy used to treat biallelic RPE65 mutation associated retinal dystrophy it is subretinal injection. FDA aprroved in 2017

Tisagenlecleucelsold under the brand name Kymriah, is a medication for the treatment of B-cell acute lymphoblastic leukemia (ALL) which uses the body’s own T cells to fight cancer (adoptive cell transfer).Acute lymphoblastic leukemia in children is more common than other types of cancer

nusinersen used in treating spinal muscular atrophy (SMA), a rare neuromuscular disorder.In December 2016, it became the first approved drug used in treating this disorder.

eliglustat used for the long-term treatment of Gaucher disease type 1

catridecacog indicated in patients with a rare clotting disorder, congenital factor XIII A-subunit deficiency, which is a kind of Factor XIII deficiency. The drug prevents bleeding in patients with this condition, and has been approved FDA in 2014.

larotrectinib used for adults and children with solid tumors that test positive for NTRK genes, which can help cancerous tumors grow. Tumors with this type of genetic change are not common but can be found in cancers of the salivary gland, thyroid, lung, and soft tissue sarcoma

grazoprevir Antiviral drug for chornic heptits c infection, hepatitis C protease inhibitor.

ipilimumab biological drugs to treat late-stage melanoma that has spread or cannot be removed by surgery

erdafitinibtreat adults with bladder cancer (urothelial cancer) that has spread or cannot be removed by surgery:

Lanadelumabpromote prevention of angioedema in patients with hereditary angioedema.

country map

Top priced drug for each manufucure country registered in SFDA

The map is interactive, You can see all countries with the highest price for each drug!

what are suspended drugs

Scientific Name Manufacture Country RegisterYear Legal Status
omeprazole Belgium 2009 Prescription
glimepiride United Arab Emirates 2012 Prescription
glimepiride United Arab Emirates 2011 Prescription
glimepiride United Arab Emirates 2011 Prescription
metformin United Arab Emirates 2009 Prescription
clarithromycin United Arab Emirates 2002 Prescription
simethicone (activated dimethicone) Switzerland 2015 OTC
venlafaxine Saudi Arabia 2018 Prescription
venlafaxine Saudi Arabia 2018 Prescription
pantoprazole sodium sesquihydrate Egypt 2017 Prescription
pregabalin Saudi Arabia 2017 Prescription
pregabalin Saudi Arabia 2017 Prescription
esomeprazole magnesium Saudi Arabia 2019 Prescription
esomeprazole magnesium Saudi Arabia 2019 Prescription
esomeprazole magnesium Saudi Arabia 2019 Prescription
esomeprazole magnesium Saudi Arabia 2019 Prescription

it seems that all of suspneded drugs might have manufacture issues or any other issues rather than a problem in a drug itself, since all drugs are still in use

Conclusion

Although Saudi pharmaceutical companies started in late 90s, but it seems we are very dependents on international pharmaceutical companies. the focus on intravenous medication was on sodium Chloride and other electrolytes, while on oral medication was on pain killers and antidepressants and anti-psychiatrics, also anti-psychiatrics are top of imported drugs, thus indicate increase mental issues on Saudi Arabia. we have emerging of serious diseases such as IHD and stroke which is the main cause of mortality in Saudi Arabia A,B. even though, patient with DM, HTN, or cancer may have depression especially if that affect their life, which make increasing of importing anti-psychiatrics is reasonable! to conculde, There are opportunities for Saudi pharmaceutical companies to focus on syntheses of other medications that are used to treat chronic disease which is incresing!.

References

Sfda.gov.sa. 2021. Overview | Saudi Food and Drug Authority. [online] Available at: https://www.sfda.gov.sa/en/overview [Accessed 13 November 2021].

Institute for Health Metrics and Evaluation. 2021. Saudi Arabia. [online] Available at: http://www.healthdata.org/saudi-arabia [Accessed 13 November 2021].

World Life Expectancy. 2021. HEALTH PROFILE SAUDI ARABIA. [online] Available at: https://www.worldlifeexpectancy.com/country-health-profile/saudi-arabia [Accessed 13 November 2021].

BinDhim, N. F., Althumiri, N. A., Basyouni, M. H., Alageel, A. A., Alghnam, S., Al-Qunaibet, A. M., … & Ad-Dab’bagh, Y. (2021). Saudi Arabia Mental Health Surveillance System (MHSS): Mental health trends amid COVID-19 and comparison with pre-COVID-19 trends. European Journal of Psychotraumatology, 12(1), 1875642. https://www.tandfonline.com/doi/full/10.1080/20008198.2021.1875642

Altwaijri, Y. A., Al‐Subaie, A. S., Al‐Habeeb, A., Bilal, L., Al‐Desouki, M., Aradati, M., … & Kessler, R. C. (2020). Lifetime prevalence and age‐of‐onset distributions of mental disorders in the Saudi National Mental Health Survey. International journal of methods in psychiatric research, 29(3), e1836. https://onlinelibrary.wiley.com/doi/full/10.1002/mpr.1836